MSD
Principal Scientist, Cell Culture & Fermentation Sciences
MSD, Rahway, New Jersey, us, 07065
Job Description
As part of Our Company’s Manufacturing Division, within the Bioprocess Drug Substance Commercialization (BDSC), the Cell Culture and Fermentation Sciences (CCFS) department provides the technical process leadership and laboratory capabilities in support of late-stage pipeline and post-market commercial manufacturing processes for vaccines and biologics. CCFS supports various commercialization activities, second generation process development including process characterization, technology transfer to internal and external manufacturing sites, manufacturing investigations, process validation, and authoring of regulatory submissions.
Under the general scientific and administrative direction of Director in the CCFS group and working in conjunction with internal and external partners, this individual will support late stage and commercial large molecule program activities within CCFS. The individual will be responsible for leading a team to support development activities, commercialization activities of late-stage pipeline and/or post-market commercial manufacturing vaccines and biologics. For commercial programs, activities include site-to-site process transfers, manufacturing investigations and trend evaluations, process enhancements, next generation process development and characterization, process validation, and regulatory submission authoring.
In this role, the successful candidate will be responsible to:
Coordinate project planning, resourcing, progress reporting, troubleshooting and people management.
Serve as the scientific/technical mentor for junior staff. Provide technical guidance in the various aspects of Cell Culture process development/commercialization for large molecule products.
Responsible for process development, process characterization and regulatory filing activities to ensure a smooth and clear path to successful PPQs and BLAs for the company's pipeline.
Manage large multifaceted projects as the leader of a cross-functional team.
Ensures project results meet requirements regarding technical quality, reliability, schedule, and cost.
Monitors performance and recommends schedule changes, cost adjustments or resource additions.
Solves technical and non-technical problems throughout the life of the project, tries to resolve problems during the design and planning phases whenever possible.
Provides timely and accurate information and status updates to project sponsors and management.
Champion compliance and safety; promote a culture of diversity, inclusion, and equity.
Minimum Education Requirement and Experience:
Bachelor’s degree in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with ten (10) years of technical expertise in cell culture and fermentation sciences, leadership and project management, and regulatory knowledge in the Pharmaceutical/Biotech industry
OR Master’s degree in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with eight (8) years of technical expertise in cell culture and fermentation sciences, leadership and project management, and regulatory knowledge in the Pharmaceutical/Biotech industry
OR Ph.D. in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with five (5) years of technical expertise in cell culture and fermentation sciences, leadership and project management, and regulatory knowledge in the Pharmaceutical/Biotech industry. Required Experience and Skills: Strong fundamental knowledge and subject matter expertise with mammalian cell culture processing of biologics (large molecule products), recent advances, and challenges in the field. Expertise in independently conducting and directing the planning, execution, analysis, and documentation of all stages of cell culture process commercialization. Experience in leadership of CMC development teams. Experience authoring technical documentation in support of the following: process performance qualification, risk assessment, control strategy, process comparability reports, and/or regulatory submissions. Adaptability and agility to prioritize and deliver complex objectives, often on tight timelines, in a rapidly changing environment. Experience and aptitude to lead, work, and collaborate in internal and external cross-functional, matrixed teams. Action-oriented, mindset for creativity; ability to take initiative, innovate, iterate, and problem-solve. Demonstrated commitment and experience to coach and mentor staff to maximize talent development and utilization. Excellent interpersonal and communication skills. Preferred Experience and Skills: Over twelve (12) years of technical expertise in cell culture and fermentation sciences, leadership and project management, and regulatory knowledge in the Pharmaceutical/Biotech industry preferred. Experience with cell culture process development for both biologics and vaccines. Experience with high throughput microbioreactor systems, and advanced in situ analytics for process monitoring and control. Experience with state-of-the-art cell culture processes including intensified inoculum/fed-batch and perfusion process development. Background in data science approaches related to cell culture and predictive modeling e.g., (metabolic flux (MFA) analysis, omics, machine learning; experience integrating PAT efforts). Experience with on-the-floor Good Manufacturing Practice (GMP) manufacturing support, familiarity with manufacturing batch record reviews and/or operations. Experience with mathematical modeling, theoretical scaling calculations, drug substance comparability, scale down establishment, computational fluid dynamics (CFD) modeling, Quality by Design (QbD) and Lean Six Sigma principles. Experience supporting/writing regulatory filings (IND, MAA, BLA) and inspections with multiple agencies (FDA, EMA, JNDA, TGA).
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OR Master’s degree in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with eight (8) years of technical expertise in cell culture and fermentation sciences, leadership and project management, and regulatory knowledge in the Pharmaceutical/Biotech industry
OR Ph.D. in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with five (5) years of technical expertise in cell culture and fermentation sciences, leadership and project management, and regulatory knowledge in the Pharmaceutical/Biotech industry. Required Experience and Skills: Strong fundamental knowledge and subject matter expertise with mammalian cell culture processing of biologics (large molecule products), recent advances, and challenges in the field. Expertise in independently conducting and directing the planning, execution, analysis, and documentation of all stages of cell culture process commercialization. Experience in leadership of CMC development teams. Experience authoring technical documentation in support of the following: process performance qualification, risk assessment, control strategy, process comparability reports, and/or regulatory submissions. Adaptability and agility to prioritize and deliver complex objectives, often on tight timelines, in a rapidly changing environment. Experience and aptitude to lead, work, and collaborate in internal and external cross-functional, matrixed teams. Action-oriented, mindset for creativity; ability to take initiative, innovate, iterate, and problem-solve. Demonstrated commitment and experience to coach and mentor staff to maximize talent development and utilization. Excellent interpersonal and communication skills. Preferred Experience and Skills: Over twelve (12) years of technical expertise in cell culture and fermentation sciences, leadership and project management, and regulatory knowledge in the Pharmaceutical/Biotech industry preferred. Experience with cell culture process development for both biologics and vaccines. Experience with high throughput microbioreactor systems, and advanced in situ analytics for process monitoring and control. Experience with state-of-the-art cell culture processes including intensified inoculum/fed-batch and perfusion process development. Background in data science approaches related to cell culture and predictive modeling e.g., (metabolic flux (MFA) analysis, omics, machine learning; experience integrating PAT efforts). Experience with on-the-floor Good Manufacturing Practice (GMP) manufacturing support, familiarity with manufacturing batch record reviews and/or operations. Experience with mathematical modeling, theoretical scaling calculations, drug substance comparability, scale down establishment, computational fluid dynamics (CFD) modeling, Quality by Design (QbD) and Lean Six Sigma principles. Experience supporting/writing regulatory filings (IND, MAA, BLA) and inspections with multiple agencies (FDA, EMA, JNDA, TGA).
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